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Corticosteroid

Prolotherapy vs. Steroid Injections for Chronic Low Back Pain

Phase 2
Waitlist Available
Research Sponsored by Naveed Natanzi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS
Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings
Must not have
Unable to reliably comprehend the protocol or reliably record data
History of Malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial found that caudal prolotherapy was more effective than conventional steroid injections for chronic low back pain.

Who is the study for?
This trial is for adults over 18 with chronic low back pain, specifically at the L4 nerve root level or below, confirmed by MRI or X-ray. They should have tried at least two other treatments like physical therapy and must not be heavy drinkers. People can't join if they have respiratory or cardiac issues, trouble understanding the study, a history of cancer, certain medical conditions that could affect participation, are pregnant or might become pregnant.
What is being tested?
The study is comparing two types of injections for chronic low back pain: caudal prolotherapy (dextrose injection) and conventional epidural steroid injections. It aims to see which treatment provides better relief from pain.
What are the potential side effects?
Possible side effects may include discomfort at the injection site, infection risk from the procedure itself, allergic reactions to injected substances, increased blood sugar levels especially in diabetics due to steroids and temporary increases in pain following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had lower back pain for over 6 months with a current pain level above 6/10.
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My lower back pain is confirmed by MRI or X-ray to affect the L4 nerve root or below.
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I have had at least 2 unsuccessful spinal injections for pain relief.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can understand the study's requirements and can accurately report my health data.
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I have had cancer before.
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I do not have any heart problems causing symptoms or instability.
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I have breathing problems that are getting worse or causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Epidural SteroidExperimental Treatment1 Intervention
80mg depo-medrol 9mL 1% lidocaine
Group II: Epidural ProlotherapyActive Control1 Intervention
10ml of 5% generic dextrose

Find a Location

Who is running the clinical trial?

Naveed NatanziLead Sponsor

Media Library

Epidural Steroid (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02116075 — Phase 2
N/A Research Study Groups: Epidural Prolotherapy, Epidural Steroid
N/A Clinical Trial 2023: Epidural Steroid Highlights & Side Effects. Trial Name: NCT02116075 — Phase 2
Epidural Steroid (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02116075 — Phase 2
~5 spots leftby Nov 2025
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